Clinical Trials Directory

Trials / Completed

CompletedNCT01396356

Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"

Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"

Status
Completed
Phase
Study type
Observational
Enrollment
25 (estimated)
Sponsor
Dhanunjaya Lakkireddy, MD, FACC · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation. Complications of ablation procedures include damage to structures near the heart from the heat energy used during the ablation procedure. These complications include damage to the esophagus (the tube through which food passes when you swallow) and stomach. A rare but often fatal complication resulting from severe heat damage is called an atrio-esophageal fistula (an abnormal connection between the heart and esophagus). However, the frequency of minimal damage to the esophagus or nerves of the gut that may go unnoticed are not known. This study is designed to determine how often atrial fibrillation ablation causes problems with the stomach and esophagus.

Conditions

Interventions

TypeNameDescription
PROCEDUREGI proceduresIf you agree to participate in the study, you will undergo a series of tests about a week before the expected ablation procedure. The same tests will be repeated 24-48 hours after the ablation. These tests include esophageal manometry, gastric emptying scan, sham feeding test and completing a symptoms questionnaire.

Timeline

Start date
2010-08-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2011-07-18
Last updated
2013-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01396356. Inclusion in this directory is not an endorsement.